Document: Coalition Letter on CREATES Act

Dear Chairman Grassley and Ranking Member Feinstein: We, the undersigned, commend you for your leadership and commitment to reducing out-of-control prescription drug prices and stopping anti-competitive abuses that keep drug prices high. We are encouraged that the Senate Judiciary Committee has noticed a markup of the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974). We thank you for your efforts to move this important piece of legislation through the Committee. We appreciate the commitment from Health and Human Services (HHS) Secretary Alex Azar and Food and Drug Administration Commissioner (FDA) Scott Gottlieb on this important issue. Both have noted their concerns with “gaming” of FDA regulatory rules to deny would-be generic competitors the ability to purchase samples of brand-name drugs necessary to conduct the FDA-required testing and bring a generic competitor to market.